Li Tao, Felton Jeremy, Lewis Johnathan, Cheng Qisen, Meredith Ryan, Lu Hsueh-Tsung, Benken Alexander, Dutta Partha P, Liao Jinhui, Zhao Xiangyu D, Matvekas Aleksas, Baker Jason, Hasler William L, Babiskin Andrew, Walenga Ross, Fang Lanyan Lucy, Lionberger Robert, Pai Manjunath P, Sun Duxin, Gianchandani Yogesh B
Center for Wireless Integrated MicroSensing and Systems (WIMS2), University of Michigan, Ann Arbor, Michigan, United States of America.
Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, United States of America.
PLoS One. 2025 Jul 11;20(7):e0327667. doi: 10.1371/journal.pone.0327667. eCollection 2025.
Fluids sampled from the gastrointestinal (GI) tract are of interest for evaluating the bioequivalence of oral medications, and more generally for evaluating GI-related diseases, and for profiling the individual gut microbiome. Existing options for capturing multiple fluid samples from specific locations in the GI tract are limited and invasive, particularly for the small intestine. Here, we report the development of an ingestible capsule for the collection of multiple fluid samples along the GI tract; we additionally report the use of data from sensors within the capsule to determine the sampling regions. The capsule has an ingestible size of Φ14 × 42 mm3. Within this volume, it includes three separate cartridges that capture and retain samples within capillaries; a stepper motor for positioning the sampling cartridges at a sampling port; a 3-axis accelerometer that enables a new method of correlating sample location; a microcontroller with wireless communication and sensor data storage capabilities; and batteries to power the device. We describe in vitro characterization and in vivo tests performed with canine models that have successfully verified the capabilities of the capsule. Fluid samples from the stomach, small intestine, and colon regions of the GI tract are identified by inertial measurements taken within the capsule, and correlated to measurements of the concentration of mesalamine (a drug used for testing) and the bile salt profile in each region, respectively.
从胃肠道(GI)采集的流体样本对于评估口服药物的生物等效性具有重要意义,更广泛地说,对于评估胃肠道相关疾病以及分析个体肠道微生物群也很重要。现有的从胃肠道特定位置采集多个流体样本的方法有限且具有侵入性,尤其是对于小肠。在此,我们报告了一种可吞咽胶囊的研发,该胶囊可沿胃肠道收集多个流体样本;此外,我们还报告了利用胶囊内传感器的数据来确定采样区域。该胶囊的可吞咽尺寸为Φ14×42 mm³。在这个体积内,它包括三个独立的药筒,用于在毛细管中捕获和保留样本;一个步进电机,用于将采样药筒定位在采样端口;一个三轴加速度计,可实现一种关联样本位置的新方法;一个具有无线通信和传感器数据存储功能的微控制器;以及为设备供电的电池。我们描述了使用犬类模型进行的体外特性研究和体内测试,这些研究和测试已成功验证了该胶囊的功能。通过胶囊内的惯性测量来识别胃肠道胃、小肠和结肠区域的流体样本,并分别将其与每个区域中用于测试的药物美沙拉嗪浓度测量值和胆汁盐谱相关联。